Chemo/Rituximab Is Effective as First-Line CLL Therapy

Chemo/Rituximab Is Effective as First-Line CLL Therapy

LUGANO, SwitzerlandThe chemotherapy/immunotherapy regimen FCR (fludarabine,
cyclophosphamide, rituximab) has produced the highest complete response (CR)
rate seen thus far in first-line treatment of chronic lymphocytic leukemia (CLL),
according to investigator Michael J. Keating, MB. The FCR regimen, which is
well tolerated, also results in molecular remissions in a "significant
number" of complete responders, said Dr. Keating, professor of medicine,
M.D. Anderson Cancer Center.

"I think we now have an outpatient regimen that can accomplish PCR [polymerase
chain reaction] negativity to a level that was formerly only achievable with
various transplant procedures," Dr. Keating said. "It will be
intriguing to follow these patients and see how durable these responses
are."

The study, which included 135 patients with CLL who received six cycles of
FCR, achieved a complete response rate of 67% (90 patients), Dr. Keating
reported at the 8th International Conference on Malignant Lymphoma (ICML
abstract 008). By comparison, front-line fludarabine (Fludara), in previous
investigations, has resulted in a 35% complete remission rate, while adding
cyclophosphamide to fludarabine increases the CR rate to 43%.

The FCR regimen is an infusion of rituximab (Rituxan) at a conventional dose
(375 mg/m²) on the first day of the first cycle, with fludarabine and
cyclophosphamide given on days 2, 3, and 4. In subsequent cycles, rituximab is
given at a higher dose (500 mg/m²) on day 1, along with the 3-day fludarabine/cyclophosphamide
couplet. Cycles are repeated every 4 weeks for a total of six cycles.

The median patient age was 57 years, or somewhat lower than in previous
studies of first-line treatment for CLL. Dr. Keating attributes this to the
"Internet phenomenon"younger patients seeking out more aggressive
therapies.

The treatment was well tolerated, with 74% of patients completing six
cycles, and only 4% completing less than three cycles.